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Completed

NCT Number: NCT00378417

Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to 24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same control vaccine (hepatitis B vaccine).

The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine. The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated.

The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.

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Key information

Conditions

Otitis Media Bacterial Infections Bacterial Infections and Mycoses Ear Diseases Gram-Positive Bacterial Infections Infections Otitis Otorhinolaryngologic Diseases Pneumococcal Infections Streptococcal Infections

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kangasala Study Clinic, Kangasala, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination
  • family living permanently in Tampere, Kangasala or Nokia
  • at least one of the parents/guardians is able to communicate fluently in Finnish
  • written informed consent obtained from a parent/guardian prior to enrollment in the study

Exclusion criteria

  • hypersensitivity to any of the components of the vaccines used in the study,
  • known or suspected impairment of immunologic function,
  • history of invasive pneumococcal disease,
  • prior vaccination with any pneumococcal vaccine,
  • prior vaccination with hepatitis B vaccine,
  • contraindications to routine childhood immunizations
  • any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child

Treatment and study plan

7-valent pneumococcal-CRM197 conjugate vaccine

Biological

7-valent pneumococcal-OMPC conjugate vaccine

Biological

Primary outcomes

  1. Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine

Secondary outcomes

  1. First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC
  • Pasteur Merieux Connaught
  • Wyeth-Lederle Vaccines

Registry information

Official study title

Efficacy Trial in Finnish Children of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Pneumococcal Serotypes in the Vaccines

Important dates

Study start
1995
Study completion
1999
First posted
Sep 20, 2006
Registry last updated
Sep 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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